Eight new medicines and six indication extensions have been recommended for approval at the European Medicines Agency’s (EMA) latests human medicines committee (CHMP), which was held virtually to help limit the spread of COVID-19.
First up in the round of decisions, the Committee recommended granting a conditional marketing authorisation for Novartis’ Zolgensma (onasemnogene abeparvovec) for the treatment of babies and young children with spinal muscular atrophy.
The advanced therapy medicinal product (ATMP) is indicated for the rare and often fatal genetic disease that causes muscle weakness and progressive loss of movement.
Next up, the virtual gathering adopted a positive opinion for more Novartis products; Atectura Breezhaler (indacaterol/mometasone furoate) and Bemrist Breezhaler (indacaterol/mometasone furoate) for the treatment of asthma, as well as recommending granting a marketing authorisation for Seqirus’ Fluad Tetra (influenza vaccine (surface antigen, inactivated, adjuvanted)) for prophylaxis against influenza.
Pretomanid FGK (pretomanid) also received a positive opinion from the Committee for the treatment of tuberculosis in combination with bedaquiline and linezolid.
Additionally, the group recommended Sanofi’s Sarclisa (isatuximab) in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of certain adult patients with relapsed and refractory multiple myeloma.
Sanofi says the indication is for those who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy.
For Sarclisa, the positive opinion was based on data from ICARIA-MM, in which the drug added to pom-dex demonstrated a statistically significant improvement of progression free survival (PFS) with a median PFS of 11.53 months compared to 6.47 months with pom-dex alone.
Celgene’s Zeposia (ozanimod) also bagged a positive opinion for the treatment of adult patients with relapsing remitting multiple sclerosis with active disease.
Mylan’s biosimilar medicine Nepexto (etanercept) also received a positive opinion for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis, non-radiographic axial spondyloarthritis), plaque psoriasis and paediatric plaque psoriasis.
In addition to the novel meds, the committee also recommended the extension of six therapeutic indications; Takeda’s Adcetris (brentuximab vedotin), Novartis’ Cosentyx (secukinumab), Janssen’s Intelence (etravirine), Dr Falk Pharma’s Jorveza (budesonide), Swedish Orphan Biovitrum’s Kineret (anakinra), and Pharming’s Ruconest (conestat alfa).
If approved, Cosentyx will be the first fully-human IL-17A inhibitor indicated for patients in Europe with nr-axSpA.
Non-radiographic axial spondyloarthritis is part of the axSpA spectrum and is a “painful and debilitating disease for which there are limited treatment options available,” added Eric Hughes, global development unit head, immunology, hepatology & dermatology at Novartis. “This positive opinion marks another step forward in our commitment to reimagine medicine in axSpA and help patients realise relief from the burdensome symptoms of their disease earlier.”
Further to the decisions, the application for an initial marketing authorisation for Doxorubicin Hydrochloride Tillomed (doxorubicin) was withdrawn, as were the applications for initial marketing authorisation for two medicines with the active substance rituximab.